K964364 is an FDA 510(k) clearance for the DISPOSABLE APRON. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).
Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on February 25, 1997, 116 days after receiving the submission on November 1, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K964364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1996 |
| Decision Date | February 25, 1997 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LYU — Accessory, Surgical Apparel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |